THE NATIONAL BLOOD POLICY

National Blood Transfusion Service Federal Ministry of Health Abuja

may 2006

CONTENTS
Pages I. II. III. IV. V. VI. VII. VIII. IX. X. XI. XII. XIII. XIV. XV. XVI. XVII. Preamble . . 3 Policy Statement 4 . Vision Statement 4 . Guiding Principles 5 . Mission Statement . 5 Objectives 6 The National Blood Service . . 7 Zonal Blood Service Centres 9 State and LGA Blood Service Centres 0 1 The Armed Forces Blood Service 1 0 Private and other Non-Governmental Health Establishments . .1 1 Blood Donor Recruitment . .2 1 Processing of Blood . .3 1 Appropriate Use of Blood . .4 1 Personnel and Human Resource Development 5 1 Technology and Research 1 6 Funding 1 6

XVIII. Quality Assurance . 1 7 XIX. XX. XXI. XXII. Records and Data System .18 Equipment and Consumables .18 Legislation 18 Appendices: I T eN t nl l dS ri a dR l e B de : h ai a Bo o o e v e n ea d o is 19 c t I : ra iain l h r a t eNain l e d u re s 20 I O g n t a C at t h z o t a H a q atr o I I O g n ainl h r a t eS aeC nr I : ra i t a C at t h tt e te 21 z o 2

FOREWORD

Blood is a living tissue,. It is the most donated tissue in medical practice and is a veritable tool in many life-saving situations if used appropriately and judiciously. Advances in medicine and technology have increased the need for blood in cases of road traffic accidents, complications of pregnancy and childbirth, various anemia and surgical emergencies. As much as blood can be life saving, its misuse could be dangerous and life threatening. Blood is specie-specific, which means that we can only use human blood for human beings and because of this, blood a very scarce resources. We have to depend on other humans for it. We need to encourage the spirit of volunteerism in our people to ensure a regular supply of this very important commodity. It is therefore necessary to have a policy that effectively addresses the issue involved in blood safety. This blood policy, which was revised by a committee which was inaugurated last August, gives clear specifications and guidelines about how activities of blood transfusion should be performed. If these polices and guidelines are implemented, there is no doubt that we would have succeeded not only in providing safe blood for countless members of our society who may need it but also in tackling one of the surest sources of transmission of HIV/AIDS.

PROF. EYITAYO LAMBO. Honourable Minister of Health 24th August, 2006.

PREFACE
As part of the on-going health sector reform programme of the Federal Government of Nigeria, the establishment of a National Blood Transfusion Service will strengthen the National Health System and its management. Nigeria is a signatory to the World Health Assembly Resolution (WHA 28.72 of 1975) which requires each member to develop a nationally coordinated blood transfusion service, based on voluntary, non-remunerated blood donation. The implementation of the National Blood Policy is therefore a major platform for the goal of providing safe, quality blood available to all who may need it.

DR ADENIKE A. ADEYEMI Director, Hospital Services, Federal Ministry of Health.

ACKNOWLEDGEMENTS
The Federal Ministry of Health acknowledges the support of several people and organisations towards the development of the National Blood Policy. Specifically, the Ministry wishes to recognize the efforts of the National Technical Committee on Blood Transfusion Services, the Health Systems Development Fund (HSDP I )ad t e U i d S ae Peie t E e g n y F n f rA D R l f (E F R fr I n h n e tts rs n m re c u d o I S ei P P A ) o t d s e providing funds which facilitated the meetings held in preparation of this policy. We sincerely appreciate the input from the various professional organisations, including the Society for Haematology and Blood Transfusion, Association of Medical Laboratory Scientists and Association of Nurses and Midwives who have all made invaluable contributions to the contents of this document. While we may not be able to acknowledge each individual who has contributed to the entire process, we would like them all to know that their efforts are greatly appreciated. Finally, we would like to thank the secretarial and support staff who have worked so hard to prepare, type, print and bind this policy document in record time.

DR. FOLAKE AYO, MBBS, FMCP National Coordinator National Blood Transfusion Service

I. 1.

PREAMBLE A National Blood Transfusion Service should be an integral part of every national

healthcare system. However, in Nigeria, blood banking and transfusion services have been fragmented, uncoordinated and unregulated and safety has not been satisfactory, despite various efforts at policy development and a certain level of implementation. Recent concerted efforts have produced the following results: (i) Formal establishment of the National Blood Transfusion Service, with two (2) functional Zonal Centres in Kaduna and Owerri; (ii) Establishment of a Demonstration Blood Centre in Abuja, with the Safe Blood for Africa Foundation (SBFAF) as technical partners; and (iii) The inauguration of an Advisory National Technical Committee.

2.

A national baseline data survey on blood transfusion was conducted during the last The survey indicated evidence of divergent and unsatisfactory

week of August 2005.

practices everywhere. The survey revealed that only about half a million units of blood were collected from private and public sources in the previous one year a grossly inadequate figure for a country of about120 million people. At Nie iscurrent level of gr a

health care delivery, it is estimated that about 1.5million units of blood per annum would be required.

3.

Furthermore, the survey revealed that in the public sector 25% and 75% respectively

were commercial and replacement donors, whilst voluntary non-remunerated donors were negligible. In the private sector, the reverse was the case, with 75% and 25% respectively 6

being commercial and replacement donors whilst voluntary donors were insignificant. This very unsatisfactory situation should not be allowed to continue. This evidence-based

appraisal underscored the urgent need for a system that would adequately address the issue of transfusion practices and blood safety in Nigeria.

4. The challenge now is to build on an earlier initiative by producing a revised National Blood Policy which would be backed by appropriate legislation and regulation.

II. 5.

POLICY STATEMENT

Blood therapy is a life-saving component of modern health care, worldwide. It is

essential that blood products be available and accessible to the generality of Nigerians, irrespective of gender, geopolitical setting, socioeconomic standing, cultural backgrounds, and other societal variables. Such products would be sourced from low-risk, voluntary, nonremunerated blood donors.

III.

VISION STATEMENT

6. The Federal Government, through the Federal Ministry of Health, accepts the ultimate responsibility of providing a comprehensive blood transfusion service in Nigeria by establishing an efficient National Blood Service. In pursuance of this goal, a National

Policy on Blood Service is being formulated. The vision is to have a quality National Blood Service that would comply with international standards and be acknowledged as one of the best in Africa.

IV.

GUIDING PRINCIPLES

7. The major guiding principles are the following: There is currently no effective or acceptable alternative to human blood for therapeutic use; Human blood and tissues are scarce national resources which should not be traded like commodities; A good blood transfusion policy should facilitate the provision of safe and adequate blood and blood products for the Nigerian population; Blood from regular, voluntary and altruistic, non-remunerated donors has been proven worldwide to be the safest for therapy; Donated blood, being a scarce national resource, must be shared equitably and used in the most effective and efficient manner; The procurement and administration of blood must protect and promote the health of both recipient and donor; and The experience and recommendations of international bodies of experts, such as the World Health Organization (WHO), the International Society of Blood Transfusion (ISBT) and others clearly suggest that a nationally organized, coordinated and regulated blood programme is the best way to achieve the desired goals.

V.

MISSION STATEMENT

8. The mission of the National Blood Service is to provide safe, quality and adequate blood in an equitable and cost- effective manner to all people resident in Nigeria. VI. OBJECTIVES

9. The objectives of this policy shall be to: Establish and coordinate blood transfusion services on a country-wide basis within the National Health Plan; Develop a system of blood donor mobilization and motivation, based entirely on a voluntary, non-remunerative donation of blood; Standardize the methods of collection, transportation, processing, testing, storage and distribution of blood, blood components and derivatives which are safe for transfusion and other medical therapy; Ensure the rational and optimal use of blood products; Provide the modalities for human resource recruitment, training,

professional and career development to satisfy the needs of the system; Encourage the development of technology and research into all aspects of blood transfusion; Maintain a cost-effective and sustainable service through appropriate budgeting and judicious use of funds; Maintain a system of total quality management (TQM) and haemovigilance at all levels of the service; Ensure the equitable distribution of equipment and consumables; 9

 Establish a data and information support system; Ensure compliance with existing universal legislation and regulations on blood services; and Relate to and co-operate with international organizations and other stakeholders in the field of blood safety.

VII. 14.

THE NATIONAL BLOOD SERVICE (NBS)

The National Blood Service (NBS) shall be the responsibility of the Honourable

Minister of Health who shall be responsible for establishing a regulatory authority for all blood services nationwide that shall accredit blood transfusion service facilities throughout the country and ensure that the facilities are operated to the prescribed regulations and standards. Specifically, the Honourable Minister shall appoint a National Coordinator of the National Blood Service (NBS) who shall: Co-ordinate and supervise all blood transfusion services in the country; Exercise appropriate financial control over the NBS; and Have the power to set up committees and bodies of experts to carry out specific functions or tasks relating to the functioning of the NBS.

15. The National Blood Service (NBS) shall be headed by a National Coordinator who shall be: medically qualified, with appropriate training and experience in blood transfusion; and be duly appointed by the Honourable Minister of Health. 10

16. The National Coordinator shall be responsible for the day to day running of the NBS. 17. There shall be a Management Committee of the NBS, comprising the National

Coordinator and the principal officers of the NBS.

18. The functions of the NBS shall be as follows: Comply with appropriate standards and issue guidelines for the practice of blood transfusion in Nigeria; Coordinate and supervise the activities of Zonal and State Blood Services, including the Federal Capital Territory, to ensure compliance with policy decisions; Develop blood donor recruitment strategies nationwide; Monitor all blood banks in the country; Identify the training needs for blood service and provide the modalities for satisfying them; Collate, analyze and publish information relating to blood service in the country; Set up a national haemovigilance system; Develop quality assurance programmes and promote research into all aspects of blood transfusion; Promote the appropriate use of blood products (homologous and autologous)

and alternatives, such as haematinics, colloids and crystalloids; and Perform any other functions as may be directed by the Honourable Minister. 11

VIII. 19.

ZONAL BLOOD SERVICE CENTRES

The NBS shall establish Zonal Blood Service Centres in each of the six geopolitical

zones in the country. The centres shall be the headquarters of all blood transfusion activities within the respective zones.

20.

A Zonal Centre shall be headed by a Zonal Coordinator who shall, preferably, be

medically qualified and has acquired training in the administration of a blood service.

21. The Zonal Coordinator shall be responsible for the day to day activities of the Zonal Centre and relate to all blood service activities within the zone.

22. The Zonal Coordinator shall report directly to the National Coordinator.

23. The Zonal Centre shall provide a model blood service for the zone where it is located.

24.

The Zonal Centre shall also serve as a reference point for all blood transfusion

activities within the respective zone.

25. The Zonal Coordinator shall organize the haemovigilance system within the zone.

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IX.

STATE AND LGA BLOOD SERVICE CENTRES

26.

States and LGAs shall establish their Blood Service Centres under the guidelines of

the NBS and such State and LGA Service Centres shall be subject to regulation by the NBS.

27. The State Blood Service Centre shall be headed by a State Coordinator who shall, preferably, be medically qualified and has acquired training in the administration of a blood service.

28.

An LGA Blood Service Centre shall be headed by a nominee of the State Coordinator

and shall have relevant training and experience.

29. Donor recruitment and blood collection shall be done at the centres so designated by the State Coordinator.

30.

The blood service of tertiary health institutions shall relate to the State or Zonal

Blood Service Centres in the State or Zone where it is located.

X.

THE ARMED FORCES BLOOD SERVICE

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31. The Nigerian Armed Forces shall operate a Blood Service under the guidelines of the NBS and shall be subject to regulation by the NBS.

32.

The Armed Forces Blood Service Centre shall be headed by a medically qualified

person with comparable qualifications to a Zonal Coordinator.

33.

The NBS shall extend training opportunities for blood bank staff to the Armed

Forces.

34. Donor recruitment and blood collection for the Armed Forces may be performed in collaboration with Zonal Centres in order to pool resources.

35.

Specialized screening of blood for the Armed Forces may be performed at Zonal

Centres if facilities are not available at the Armed Forces Blood Service Centre.

36.

The Armed Forces Blood Service Centre(s) shall relate with the respective Zonal

Blood Service Centre(s) in the zone.

XI. 37.

PRIVATE AND OTHER NON-GOVERNMENTAL HEALTH ESTABLISHMENTS Health establishments within the State, run by Non-Governmental Organizations

(NGOs) or private establishments may maintain blood-banking facilities only. Their activities may include the collection of blood from donors only if they are so designated by the State Coordinator. 14

38. They shall be accredited by the NBS to operate a blood bank and shall comply with all the guidelines issued by the NBS. XII. BLOOD DONOR RECRUITMENT

39. Blood donations shall be based on the principle of regular, voluntary, non-remunerative donation.

40. Financial reward for the donation of blood or blood component shall be prohibited. Donor appreciation by the giving of tokens, certificates, badges and the refund of direct transport expenses are acceptable.

41.

Donor motivation and mobilization shall be promoted through extensive awareness

programmes, such as organized donor drives, information/education/communication (IEC) materials, school and public campaigns, print and electronic media, jingles, billboards, posters and other methods.

42.

Attention to donor safety, care and comfort shall be paramount throughout the

National Blood Service.

43. Donor selection, deferral and counselling and appropriate record keeping shall be as specified in the NBS guidelines.

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44. The family replacement donation system shall be gradually phased out as voluntary donation programmes become established.

45. Specific training shall be given to workers in the donor units to promote efficiency and donor-friendly attitudes.

46.

Cooperation shall be sought from local communities, government authorities, non-

governmental and voluntary agencies, and faith-based organizations in the motivation and mobilization of voluntary donors.

47. Blood collection from prospective donors recruited by communities, non-governmental and voluntary agencies, faith-based organizations and private organizations shall be done only at designated centres.

XIII. 48.

PROCESSING OF BLOOD

All donor blood for transfusion shall be screened for specified Transfusion-

Transmissible Infections, including Human Immunodeficiency Virus (HIV), Hepatitis B and C, and Syphilis.

49. It shall be an offence to issue or transfuse unscreened blood or blood components.

50. All handling and processing of blood and record keeping shall conform with technical guidelines issued by the NBS. 16

51. The principle of a l c a tan appropriate temperature shall be maintained for c d hi a o n the storage and transportation of blood products throughout the NBS. 52. Compliance with National Technical Guidelines by all blood services nationwide shall be monitored and verified by an Inspectorate System of the NBS. Sanctions shall be applied where necessary.

53. National cross-border exchange of blood and blood products shall be with the explicit approval of the Honourable Minister of Health.

XIV.

APPROPRIATE USE OF BLOOD

54. The prescription and administration of blood and blood products shall be under the authority of a registered medical practitioner.

55. The NBS Technical Guidelines, with appropriate record keeping and haemovigilance, shall be observed by all health personnel handling and /or administering blood and blood products.

56. National sufficiency in blood and blood products supply shall be promoted and wastage reduced to the minimum, through ar g g sse (e moving excess blood products to b i i yt m i . dn ., areas of demand) throughout the NBS.

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57. To maximize the benefits of blood therapy, the NBS shall promote the application of internationally accepted principles of blood component therapy, including autologous techniques.

58. The use of alternatives to blood, such as colloids, crystalloids and haematinics where appropriate, shall be promoted by the NBS.

59.

Strategies for the reduction of transfusion requirements, such as prevention and

early diagnosis and treatment of anaemia, shall be promoted by the NBS.

60.

The establishment of State and Hospital Transfusion Committees, under the

guidelines issued by the NBS, shall be promoted throughout the country.

61. In order to augment national blood supply, the NBS may, with the permission of the Honourable Minister of Health, enter into bilateral agreements for the supply of blood components, etc.

XV.

PERSONNEL AND HUMAN RESOURCE DEVELOPMENT

62. The principle of professionalism shall be applied to all operations of the NBS.

63.

Conditions of service within the NBS shall be determined by the shall conform to the

existing Public Service rules.

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64.

Programmes of orientation, continuous education and in-service training shall be

established for all categories of staff within the NBS.

65.

Career structures which do not already exist in the Public Service shall be

established to meet the peculiar needs of the NBS and appropriate training programmes created to produce the required cadres.

66. The NBS shall encourage and cooperate with higher educational institutions in Nigeria to establish training programmes in Blood Transfusion Medicine and Science.

67. All workers in the NBS shall require cover by a form of professional indemnity.

XVI.

TECHNOLOGY AND RESEARCH

68. As far as possible, appropriate and uniform technology shall be applied throughout the operations of the NBS.

69. The NBS shall fund research and development of appropriate local technology.

XVII.

FUNDING

70. Funding of the NBS shall primarily be the responsibility of the Federal, State and Local governments of Nigeria. The Federal government shall be responsible for funding the operations of the NBS at Federal and Zonal levels, while the State and Local governments shall fund operations at State and Local Government Area levels respectively. 19

71. The Honourable Minister may authorize additional funds and other forms of assistance from international donor agencies, multilateral agreements, non-governmental

organizations, and others.

72.

While the NBS shall be guided by the principle of a t n -for-po i og n ain i o rf rai t ,t t z o

shall conduct its operations with a view towards cost-effectiveness and sustainability.

73. The practice of partial cost-recovery shall apply throughout the Service.

XVIII.

QUALITY ASSURANCE

74. National standards for the accreditation of blood services shall be established by the regulatory body established by the Honourable Minister.

75. Operational Guidelines and Standard Operating Procedures for all areas of service shall be developed by the National Blood Service (NBS) and shall be applied nationwide.

76. A system of Internal Quality Control and External Quality Assurance shall be set up and supervised by the NBS.

77. The NBS shall conform with the Factory Act, Good Manufacturing Practice (GMP), Food and Drug Regulations, and WHO Technical Guidelines where relevant.

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XIX.

RECORDS AND DATA SYSTEM

78. The NBS shall ensure that appropriate records are kept in a uniform and specified manner while at the same time maintaining confidentiality.

79. An inventory system for all stock shall be established. 80. All operations of the NBS shall be computerized.

XX.

EQUIPMENT AND CONSUMABLES

81. The National Headquarters of the NBS shall give standard guidelines for the purchase of equipment and consumables.

82. The National Blood Service shall ensure regular supply of consumables to the service.

XXI. 83.

LEGISLATION

This policy shall be backed up by appropriate legislation.

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APPENDIX 1 THE NATIONAL BLOOD SERVICE AND RELATED BODIES

FMOH

NBS NATIONAL HEADQUARTERS

ARMED FORCES BLOOD SERVICE

ZONAL BLOOD SERVICE CENTRE

STATE BLOOD SERVICE CENTRE FORCES BLOOD BANKS. LGA BLOOD SERVICE CENTRE

TERTIARY HEALTH INSTITUTIONS

PRIVATE BLOOD BANKS

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APPENDIX II ORGANISATIONAL CHART AT THE NATIONAL HEADQUARTERS

NATIONAL CORDINATOR

CLINICAL SERVICES

LABORATORY SERVICES

ADMINISTRATION.

AUDIT

DONOR ORGANISATION

RESEARCH

PERSONNEL

FINANCE LABORATORY SERVICE HAEMOVIGILANCE

TRAINING

PLANNING STATISTICS

M&E

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APPENDIX I11

ORGANIZATIONAL CHART AT THE STATE CENTRE

STATE DIRECTOR

CLINICAL SERVICES AND TRAINING

DONOR ORGANISATION

LAB SERVICES

ADMINISTRATION

LGA

24